Public GMP Inspection Reports


Public Good Manufacturing Practices (GMP) Inspection Reports

Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly and Children (MOHCDGEC) responsible for protecting and promoting public health by ensuring quality, safety and effectiveness of medicines and medical devices. TMDA (formerly known as Tanzania Food and Drugs Authority) was established in 2003 after enactment by the Parliament of the Tanzania Food, Drugs and Cosmetics Act, Cap 219.

TMDA is ranked as Maturity Level 3 institution by the World Health Organization (WHO) since April, 2019 implying that the implemented regulatory systems and functions are sufficient to protect and promote public health through ensuring the quality, safety and efficacy of medicines.

Among other regulatory functions, TMDA inspect pharmaceutical manufacturing facilities to verify their compliance to minimum Good Manufacturing Practices (GMP).

In-line with WHO’s requirement on promoting transparency, accountability and communication, the Authority publishes inspection reports of manufacturing facilities that have complied with minimum GMP requirements as per the East African Community (EAC) GMP compendium.

The published inspection reports provide an overview of the GMP inspection and give a summary of the observations and findings made during the inspection at various sites worldwide. The reports are drafted in such a way that technical terms are either avoided or used only when necessary, so that they can be easily understood by the general public.

Domestic manufacturing facilities are inspected at least once per year and once after every three (3) years in case of foreign premises. Nevertheless, the Authority may inspect facility at any time whenever necessary.

GMP Inspection Summary Reports

S/NNAME
1ASTRA Lifecare (India) PVT LTD
2BIOLOGICAL E. LTD, Telangana, India
3EMCURE Pharmaceuticals Ltd, Maharashtra, India
4Human Biologicals Institute (A Division of Indian Immunologicals Limited)
5MACLEODS Pharmaceuticals Limited, India
6(MANKIND PHARMA Limited Unit I)
7MEDREICH Limited, Unit 8, Bangalore, India
8TENAMYD Pharmaceutical Corporation, Vietnam
9ELYS Chemical Industries Ltd Unit-Ii, Kenya
10 MANEESH Exports (EOU), India
11Shanghai Dahua Pharmaceutical CO. LTD, Shanghai, China
12Premium Serums and Vaccines PVT.LTD,India
13NEOPHARMA, Abu Dhabi, UAE
14NAARI Pharma Private LTD, India
15MJ Biopharma Private Limited
16EUGIA Pharma Specialties LTD
17BETA Drugs Limited
18Aurobindo Pharma LTD Unit-XVI, Telangana, India
19 Aurobindo Pharma - Unit VII, India